Negative selection bias for women inclusion in a clinical trial.

INTRODUCTION: Despite the growing awareness towards the importance of adequate representation of women in clinical trials among patients treated with percutaneous coronary intervention (PCI), available evidence continues to demonstrate a skewed distribution of study populations in favour of men. METHODS AND RESULTS: In this pre-specified analysis from the MASTER DAPT screening log and trial, we aimed to investigate the existence of a negative selection bias for women inclusion in a randomized clinical trial. A total of 2847 consecutive patients who underwent coronary revascularization across 65 participating sites, during a median of 14 days, were entered in the screening log, including 1749 (61.4%) non-high bleeding risk (HBR) and 1098 (38.6%) HBR patients, of whom 109 (9.9%) consented for trial participation. Female patients were less represented in consented versus non-consented HBR patients (22% versus 30%, absolute standardized difference: 0.18) and among non-consented eligible versus consented eligible patients (absolute standardized difference 0.14). The observed sex gap was primarily due investigators' choice not to offer study participation to females because deemed at very high risk of bleeding and/or ischemic complications, and only marginally to a slightly higher propensity of females compared to males to refuse study participation. CONCLUSIONS: Female HBR patients undergoing PCI are less prevalent, but also less likely to participate in the trial than male patients, mainly due to investigators' preference.

Severity of Coronary Artery Disease by Friesinger Score Among Women With Acute Coronary Syndrome in a Tertiary Care Hospital in Bangladesh.

BACKGROUND: The chance of coronary artery disease (CAD) is much higher in women who have gone through menopause than in those who have not, owing to hormonal defense against atherosclerosis. More advanced CAD and several comorbidities were observed in postmenopausal women. Nevertheless, there is a paucity of information comparing the angiographic severity of acute coronary syndrome (ACS) in premenopausal and postmenopausal women of different ages. This research sought to determine the Friesinger score's use in evaluating the degree of CAD in premenopausal and postmenopausal women with ACS. METHODS: A total of 145 female patients with ACS were included in this cross-sectional observational research. Depending on the stage of menopause, they were categorized into two groups: group I (premenopausal) and group II (postmenopausal). The study examined the differences in clinical data and the severity of coronary angiographic features based on the Friesinger score between the premenopausal and postmenopausal ACS groups. RESULTS: A statistically significant difference (p = 0.001) was found in the mean age of premenopausal ACS patients, which was 41.53 ± 5.45 years, and postmenopausal ACS patients, which was 57.23 ± 7.45 years. Between the premenopausal group (31.4% vs. 17.1%; p = 0.04 and 31.4% vs. 15.7%; p = 0.002) and postmenopausal group (48.6% vs. 20%; p = 0.001), there was a greater prevalence of normal coronary angiography, single-vessel disease, and triple-vessel disease. Comparing the postmenopausal group to the premenopausal group, the high to intermediate Friesinger score (11-15) was found to be considerably higher (2.9% vs. 1.4%; 72.9% vs. 50%; p = 0.003). CONCLUSION: Prior to menopause, single-vessel disease and normal coronary angiography were more common, whereas postmenopausal individuals had triple-vessel disease. The postmenopausal group's CAD was found to be more severe than the premenopausal group's according to the Friesinger score used for severity evaluation.

Abbreviated or Standard Dual Antiplatelet Therapy by Sex in Patients at High Bleeding Risk: A Prespecified Secondary Analysis of a Randomized Clinical Trial.

Importance: Abbreviated dual antiplatelet therapy (DAPT) reduces bleeding with no increase in ischemic events in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention (PCI). Objectives: To evaluate the association of sex with the comparative effectiveness of abbreviated vs standard DAPT in patients with HBR. Design, Setting, and Patients: This prespecified subgroup comparative effectiveness analysis followed the Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated vs Standard DAPT Regimen (MASTER DAPT) trial, a multicenter, randomized, open-label clinical trial conducted at 140 sites in 30 countries and performed from February 28, 2017, to December 5, 2019. A total of 4579 patients with HBR were randomized at 1 month after PCI to abbreviated or standard DAPT. Data were analyzed from July 1 to October 31, 2022. Interventions: Abbreviated (immediate DAPT discontinuation, followed by single APT for ≥6 months) or standard (DAPT for ≥2 additional months, followed by single APT for 11 months) treatment groups. Main Outcomes and Measures: One-year net adverse clinical events (NACEs) (a composite of death due to any cause, myocardial infarction, stroke, or major bleeding), major adverse cardiac or cerebral events (MACCEs) (a composite of death due to any cause, myocardial infarction, or stroke), and major or clinically relevant nonmajor bleeding (MCB). Results: Of the 4579 patients included in the analysis, 1408 (30.7%) were women and 3171 (69.3%) were men (mean [SD] age, 76.0 [8.7] years). Ischemic and bleeding events were similar between sexes. Abbreviated DAPT was associated with comparable NACE rates in men (hazard ratio [HR], 0.97 [95% CI, 0.75-1.24]) and women (HR, 0.87 [95% CI, 0.60-1.26]; P = .65 for interaction). There was evidence of heterogeneity of treatment effect by sex for MACCEs, with a trend toward benefit in women (HR, 0.68 [95% CI, 0.44-1.05]) but not in men (HR, 1.17 [95% CI, 0.88-1.55]; P = .04 for interaction). There was no significant interaction for MCB across sex, although the benefit with abbreviated DAPT was relatively greater in men (HR, 0.65 [95% CI, 0.50-0.84]) than in women (HR, 0.77 [95% CI, 0.53-1.12]; P = .46 for interaction). Results remained consistent in patients with acute coronary syndrome and/or complex PCI. Conclusions and Relevance: These findings suggest that women with HBR did not experience higher rates of ischemic or bleeding events compared with men and may derive particular benefit from abbreviated compared with standard DAPT owing to these numerically lower rates of events. Trial Registration: ClinicalTrials.gov Identifier: NCT03023020.

Impact of real-time optical coherence tomography and angiographic coregistration on the percutaneous coronary intervention strategy.

Background: The use of optical coherence tomography (OCT) with angiographic coregistration (ACR) during percutaneous coronary intervention (PCI) for procedural decision-making is evolving; however, large-scale data in real-world practice are lacking. Aims: Our study aims to evaluate the real-time impact of OCT-ACR on clinician decision-making during PCI. Methods: Patients with angiographic diameter stenosis >70% in at least one native coronary artery were enrolled in the study. The pre- and post-PCI procedural strategies were prospectively assessed after angiography, OCT, and ACR. Results: A total of 500 patients were enrolled in the study between November 2018 and March 2020. Among these, data related to 472 patients with 483 lesions were considered for analysis. Preprocedural OCT resulted in a change in PCI strategy in 80% of lesions: lesion preparation (25%), stent length (53%), stent diameter (36%), and device landing zone (61%). ACR additionally impacted the treatment strategy in 34% of lesions. Postprocedural OCT demonstrated underexpansion (15%), malapposition (14%), and tissue/thrombus prolapse (7%), thereby requiring further interventions in 30% of lesions. No further change in strategy was observed with subsequent postprocedural ACR. Angiographic and procedural success was achieved in 100% of patients, and the overall incidence of major adverse cardiovascular events at 1 year was 0.85%. Conclusions: The outcomes reflect the real-time impact of OCT-ACR on the overall procedural strategy in patients undergoing PCI. ACR had a significant impact on the treatment strategy and was associated with better clinical outcomes at 1 year after index PCI. OCT-ACR has become a practical tool for improving outcomes in patients with complex lesions.

Assessment of subclinical left ventricular systolic dysfunction in patients with asymptomatic severe aortic stenosis with preserved left ventricular systolic function by three-dimensional speckle tracking echocardiography.

OBJECTIVES: Left ventricular dysfunction and remodeling can occur as a result of aortic valve stenosis (AS). Three-dimensional speckle tracking echocardiography (3D-STE) can detect early left ventricular myocardial dysfunction even before ejection fraction declines. The purpose of this study was to look at the relationship between various myocardial strain parameters measured by 3D-STE in asymptomatic severe AS patients from Bangladesh. METHODS: This study included 46 patients with asymptomatic severe AS but preserved LV systolic function (mean age 50.11 ± 12.66 years, LVEF 63.78 ± 3.95%, AS group) and 33 healthy subjects with no cardiovascular disease (mean age 48.21 ± 4.53 years, LVEF 65.15 ± 3.13%, control group). 3D-STE was used to measure left ventricular global myocardial strain parameters such as peak systolic longitudinal strain (PSLS), circumferential strain, radial strain, and area strain. RESULTS: The AS group had significantly thicker interventricular septum and posterior ventricular wall than the control group (1.49 ± .19 cm vs. .81 ± .09 cm, p < .001; 1.73 ± 1.71 cm vs. .81 ± .10 cm, p = .003, respectively.) In the AS group, the Indexed Aortic Valve Area (AVA) was significantly lower than in the control group. (.29 ± .10 vs. 2.03 ± .18, p < .001, respectively). In terms of LVEF (p = .102), left ventricular end diastolic volume (p = .075), or left ventricular end systolic volume (p = .092), no significant inter-group difference was found. However, global PSLS (-10.75 ± 2.27 vs. -16.42 ± 2.76, p < .001), circumferential strain (-14.26 ± 3.40 vs. -16.64 ± 2.56, p = .001), area strain (-22.70 ± 4.19 vs. -26.45 ± 9.90, p = .024) and radial strain (32.20 ± 8.77 vs. 41.00 ± 7.52, p < .001) in the AS group were significantly lower than in the control group. CONCLUSION: Our findings showed reductions in left ventricular global myocardial strains, particularly PSLS in patients suffering from asymptomatic severe AS in Bangladesh; this is consistent with other studies. Reduced area strain, detectable with 3D-STE, is also consistent with that pattern.

Complementary evidence on the performance of coronary stents generated by a randomized controlled trial and a worldwide registry.

BACKGROUND: Large-scale registries can provide valuable complementary data to randomized controlled trials (RCT) for the postmarketing evaluation of coronary stents, but their scientific relevance remains debated. METHODS: We sought to compare the evidence on the performance of a single coronary stent platform generated by the RCT for its regulatory approval and a well-conducted international registry. Patients treated with the Ultimaster coronary stent in the CENTURY II (CII-UM) trial (n = 551) were compared to patients in the real-world e-ULTIMASTER (e-UM) registry (n = 35,389). All major events were adjudicated by an independent clinical event committee in both studies. Propensity weighted analysis was used to balance baseline and procedural differences between the 2 populations. RESULTS: Coronary artery disease was more complex in e-UM compared to CII-UM, including more acute coronary syndromes, multivessel disease, left main, arterial, or venous grafts, and chronic total occlusions (P < .005 for all). At one-year follow-up and after excluding periprocedural myocardial infarction (MI) there was no statistically significant difference between CII-UM and e-UM regarding all-cause death (hazard ratio [HR] 0.55, 95% confidence interval [CI] 0.26-1.20, P = .14), cardiac death (HR 0.71, 95% CI 0.29-1.72, P = .45), target lesion failure (HR 1.18, 95% CI 0.78-1.78, P = .44), and target vessel MI (HR 0.76, 95% CI 0.24-2.38, P = .63). However, target vessel revascularization rate was significantly higher in CII-UM than in e-UM, HR 1.78, 95% CI 1.23-2.56, P = .002. CONCLUSIONS: A well-conducted large-scale registry can provide valuable complementary evidence to RCTs on the postmarket performance of new coronary stents, across a wider range of uses and various geographic areas.

Severity of Coronary Artery Diseases Among Pre- and Postmenopausal Women With Acute Coronary Syndrome: A Hospital-Based Study in Bangladesh.

BACKGROUND: Postmenopausal women present with more severe coronary artery disease (CAD) in addition to multiple comorbidities. However, there are limited data available to compare the risk factors, clinical characteristics, and angiographic severity of CAD between pre- and postmenopausal women with the acute coronary syndrome (ACS). AIM: This study aimed to assess and compare the severity of CAD in pre- and postmenopausal women with ACS. METHODS: This cross-sectional observational study was conducted at the Department of Cardiology of NHFH RI. A total of 140 female patients with ACS were enrolled and then divided into Group I (premenopausal) and Group II (postmenopausal) on the basis of menopause history. Clinical data and coronary angiographic severity were compared between both groups. RESULTS: The mean age of the premenopausal group was 41.53 ± 5.45 years, and that of the postmenopausal group was 57.23 ± 7.45 years. Family history of premature CAD was significantly more common in the premenopausal group than in the postmenopausal group (35(50%) vs. 23(32.9%); p=0.017)). DM and smokeless tobacco were more prevalent in the postmenopausal group (48(68.6%) vs. 28(40%); p=0.001 and 14(20%) vs. 2(2.9%); p=0.002). Atypical presentation was more common in the premenopausal group (21(30%) vs. 9(12.9%); p=0.013). Most of the patients in both groups presented with unstable angina followed by NSTEMI and STEMI. Mean left ventricular ejection fraction was lower in the postmenopausal group than in the premenopausal group (50.71 ± 8.38% vs. 53.74 ± 7.46%; p=0.026). Normal coronary angiogram and single-vessel disease were more prevalent in the premenopausal group (22(31.4%) vs. 12(17.1%); p=0.04) and (22(31.4%) vs. 11(15.7%); p=0.002), whereas triple-vessel disease was more prevalent in the postmenopausal group (34(48.6% vs. 14(20%); p=0.001). The left anterior descending artery was the most commonly involved vessel in the postmenopausal group (67(95.7%) vs. 60(85.7%); p=0.04). Finally, the mean Gensini score was higher in the postmenopausal group than in the premenopausal group (56.1 ± 43.4 vs. 33.5 ± 36.9; p=0.001). CONCLUSION: Family history of premature CAD and atypical presentation were common in premenopausal ACS patients. DM and smokeless tobacco use were more prevalent in the postmenopausal group than in the premenopausal group. Normal coronary angiogram and single-vessel disease were more prevalent in the premenopausal group, and triple-vessel disease was more common in the postmenopausal group. CAD was more severe in the postmenopausal group.

Safety and effectiveness of percutaneous coronary intervention using rotational atherectomy and new-generation drug-eluting stents for calcified coronary artery lesions in patients with chronic kidney disease.

AIM: Coronary artery calcification is an important factor influencing revascularisation outcomes in patients with chronic kidney disease (CKD). Lesion preparation using rotational atherectomy (RA) may help adequately modify calcified plaques and facilitate the achievement of optimal clinical outcomes in these patients. In this study, we assessed the safety and effectiveness of percutaneous coronary intervention (PCI) using RA followed by new-generation drug-eluting stent (DES) implantation in patients with CKD and calcified coronary artery disease (CAD). METHODS AND RESULTS: From November 2014 to October 2019, a total of 203 patients with calcified CAD who underwent RA followed by second- or third-generation DES implantation at our centre were included in the study. Mild, moderate, and severe CKD was present in 38%, 55.5%, and 6.5% of the patients, respectively. Diffused coronary calcifications were present in 85%. Procedural success was 97.5% with minimal periprocedural complications. In-stent restenosis occurred in one patient (0.5%); major adverse cardiovascular and cerebrovascular events were reported in 22 patients (10.8%); cardiac death occurred in eight patients during follow-up. CONCLUSION: Percutaneous coronary intervention using RA followed by second- or third-generation DES implantation is feasible and safe with high procedural success and low in-stent restenosis in CKD patients with calcified coronary lesions.

May Measurement Month 2019: an analysis of blood pressure screening results from Bangladesh.

According to the Non-communicable disease Risk Factors Survey of 2018, more than one-fifth (21.0%) of adults aged 25 years or older have hypertension and one-third of the adults did not have their blood pressure (BP) measured in their lifetime in Bangladesh. The National Heart Foundation of Bangladesh participated in May Measurement Month (MMM) 2017 and 2018 as well as this 2019 as a part of a global initiative aimed at raising awareness of high BP and to act as a temporary solution to the lack of screening programmes worldwide. This opportunistic screening of voluntary participants aged ≥18 years was carried out from May to July 2019. Data were collected from 100 screening sites in 16 districts in Bangladesh. BP measurement, the definition of hypertension, and statistical analysis followed the MMM protocol. Data on 24 941 individuals were analysed. Among the participants, 12 658 (50.8%) were female. After multiple imputation, 6990 (28.0%) had hypertension. Among the 6990 participants with hypertension, 5007 (71.6%) were on antihypertensive medication and 5331 (76.3%) were aware of having hypertension. Among 6990 participants with hypertension, 3217 (46.0%) had controlled BP (<140/90 mmHg) and among the participants with hypertension and on antihypertensive medication, 64.2% had controlled BP. Opportunistic BP screening can identify significant numbers of people with raised BP and thus assist in the prevention of cardiovascular diseases.

Clinical Presentation, Management and In-Hospital Outcome of Healthcare Personnel With COVID-19 Disease.

Objective Healthcare personnel (HCP) are undoubtedly one of the major frontline fighters in the coronavirus disease 2019 (COVID-19) pandemic. Therefore, it comes as no surprise that many HCP have become infected by COVID-19 globally. The infection of HCP has received great attention in social media and is frequently reported from different parts of the world. However, there are few scientific reports addressing this aspect of the COVID-19 pandemic. The aim of this study was to evaluate the characteristics of clinical presentation, treatment, and outcome of COVID-19 infection among the HCP of our setting. Methods This cross-sectional study was performed in the National Heart Foundation Hospital & Research Institute of Bangladesh from April 29 to July 20, 2020. HCP employed in this hospital who experienced fever or respiratory symptoms or came in close contact with COVID-19 patients at home or their workplace were included in this study. The presence of COVID-19 disease was confirmed by real-time reverse transcriptase-polymerase chain reaction on nasopharyngeal samples. A total of 394 HCP were sampled and 139 had a positive corona test. Structured interviews were conducted to document symptoms for all HCP with confirmed COVID-19. Data analysis was performed in July 2020. Results Out of 1,409 HCP, 139 subjects tested positive for COVID-19. Among the HCP, infection rate was 9.86%. The mean age of the study population was 34.08±11.11 years (range: 20-69 yrs), of whom 82 (59%) were female. Most of this cohort were nurses (56 [40.3%]) and physicians (25 [18%]), and the remaining 58 (41.7%) were other staff. The mean duration of onset of symptoms to test was 2.89±2.07 days. The most common symptoms were fever (84.2%), fatigue (56.1%), cough (54%), body ache (39.6%), headache, and anosmia (38.8%). Most subjects had mild disease (125 [93%]), three (2.1%) of the HCP had moderate disease and one (0.7%) had severe disease. Ten of the HCP (7.2%) were asymptomatic. Most of them were treated either by ivermectin plus azithromycin or ivermectin plus doxycycline. Only 20 (14.4%) of the HCP were hospitalized, while others were treated either in home isolation (59.7%) or in institutional isolation (25.9%). Recovery was almost uneventful except one healthcare worker who died. Conclusion Most HCP had mild symptoms and a few of them were asymptomatic also. HCP with mild COVID-19 symptoms may be treated in home or institutional isolation. As they are a vulnerable group for infection, providing adequate protection to HCP is absolutely mandatory to safeguard them from this pandemic.

May Measurement Month 2018: an analysis of blood pressure screening results from Bangladesh.

Elevated blood pressure (BP) is a growing burden worldwide, leading to over 10 million deaths each year. According to Non-communicable disease (NCD) Risk Factors Survey Bangladesh 2010, one-fifth (21.9%) of adults aged 25 years or more have hypertension. Almost one-third of the adult population did not have their BP measured in their lifetime in Bangladesh. National Heart Foundation of Bangladesh participated in May Measurement Month (MMM) 2018 as a part of a global initiative aimed at raising awareness of high BP and to act as a temporary solution to the lack of screening programmes nationally. An opportunistic cross-sectional survey of volunteers aged ≥18 years was carried out in May 2018. Blood pressure measurement, the definition of hypertension and statistical analysis followed the MMM protocol. Data were collected from 10 screening sites in 9 districts in Bangladesh. A total of 5208 individuals were screened during MMM18. After multiple imputation, 1750 (33.6%) had hypertension. Among the 1750 participants with hypertension, 1312 (75.0%) were aware of having hypertension. Among those that were not on antihypertensive medication, 15.2% were hypertensive and among those that were on antihypertensive medication 33.6% had uncontrolled hypertension. The present study showed that opportunistic screening can identify significant numbers of people with raised BP. A periodic public health programme at a national level needs to be initiated to increase hypertension detection and control rates and thus for prevention of cardiovascular diseases.

Proximal Left Anterior Descending Artery Treatment Using a Bioresorbable Polymer Coating Sirolimus-Eluting Stent: Real-World Outcomes From the Multicenter Prospective e-Ultimaster Registry.

Background Guidelines recommend heart team discussion and coronary artery bypass graft consideration in patients with proximal left anterior descending (LAD) artery stenosis. Evidence suggests that outcomes of proximal LAD angioplasty might not differ from treatment of nonproximal LAD locations. We aim to determine clinical outcomes of patients undergoing percutaneous coronary intervention in the proximal LAD segment in comparison with nonproximal LAD angioplasty, using a thin-strut drug-eluting stent. Methods and Results In this analysis of the e-Ultimaster registry, patients undergoing angioplasty in the proximal LAD territory were compared with those treated in nonproximal LAD locations. Multivariate analysis and propensity score were used to adjust for differences among the groups. The primary outcome was target lesion failure: a composite of cardiac death, target-lesion-related myocardial infarction, and/or clinically driven target lesion revascularization at 1-year follow-up. Of the 17 805 patients (mean age, 64.2±11; 76% male), 5452 (30.6%) underwent proximal LAD and 12 353 (69.4%) nonproximal LAD percutaneous coronary intervention. Patients in the proximal LAD group had more multivessel disease (48.7% versus 43.5%; P<0.001) and 2-fold more bifurcations lesions (18.8% versus 9.2%; P<0.0001). After propensity-weighted adjustment, target lesion failure did not differ between the groups (3.3% versus 2.9%; P=0.17 for proximal LAD versus nonproximal LAD angioplasty, respectively). In multivariate analysis, proximal LAD treatment was not an independent predictor of target lesion failure (odds ratio, 1.07; 95% CI, 0.88-1.31; P=0.48). Conclusions At 1-year follow-up, patients had similar clinical outcomes independent of stenting location, questioning whether proximal LAD treatment should be regarded differently from stenting in any other coronary artery territory.

May Measurement Month (MMM) 2017: an analysis of blood pressure screening results in Bangladesh-South Asia.

Elevated blood pressure (BP) is a growing burden worldwide, leading to over 10 million deaths each year. Based on the findings of the non-communicable disease Risk Factors Survey Bangladesh 2010, the prevalence of hypertension in adults 25 years or older in Bangladesh is 20.1%. The Bangladesh Demographic Health Survey, 2011 showed that approximately 50% of those affected are unaware of their hypertensive condition. The May Measurement Month 2017 (MMM17) is a global initiative of the International Society of Hypertension (ISH) aimed at raising awareness of high BP. We participated in MMM17 to raise awareness of hypertension screening and identify those with elevated BP who were unaware, and those on treatment with still uncontrolled hypertension. Following the standard protocol designed by the ISH, we participated in MMM17, an opportunistic cross-sectional survey of volunteers aged ≥18. It was carried out in May 2017. BP measurement, the definition of hypertension and statistical analysis followed the standard MMM protocol. Data were collected from 35 screening sites in 33 districts in Bangladesh. Personnel from several government and non-government organizations volunteered in this huge event. A total of 11 418 individuals were screened during MMM17, of which 5401 (47.3%) were found to have hypertension. Of 8365 individuals not receiving anti-hypertensive medication, 2348 (28.1%) were hypertensive. Of 3053 individuals receiving anti-hypertensive medication, 1594 (52.2%) had uncontrolled BP. MMM17 was the largest BP screening campaign undertaken in Bangladesh. This study suggests that opportunistic screening can identify significant numbers of people with raised BP. A periodic public health programme at a national level needs to be initiated to increase hypertension detection and control rate and thus for the prevention of cardiovascular diseases.

Identification of significant coronary artery disease in patients with non-ST segment elevation acute coronary syndrome by myocardial strain analyses using three dimensional speckle tracking echocardiography.

BACKGROUND: Speckle-tracking imaging is a novel method for assessing left ventricular function and ischemic changes. This study aimed to predict the presence of significant coronary artery stenosis in patients with non-ST-segment elevation acute coronary syndrome (NSTE-ACS) by 3D strain analysis using speckle tracking echocardiography (3DSTE) at rest. METHODS: This cross-sectional study included a total 60 patients with NSTE-ACS who underwent 3DSTE immediately prior to coronary angiography. Subsequently, patients undergone coronary angiogram (CAG) and divided into two groups; group- I: significant stenosis (n = 36), group-II: non-significant stenosis (n = 24). RESULTS: Global peak systolic longitudinal strain (GPSLS), circumferential strain (CS), area strain (AS), and radial strain (RS) were obtained successfully in 60 patients. All strain parameters were significantly reduced in patient group of significant stenosis. Receiver operating characteristic (ROC) curve analysis demonstrated that GPSLS could effectively detect patients with significant stenosis (area under ROC curve = 0.840, 95% CI = 0.735-0.945). GPSLS with a cutoff value of -13.50% showed good sensitivity and specificity for predicting significant stenosis (sensitivity 88.9% and specificity 70.8%). CONCLUSION: Global peak systolic longitudinal strain using 3D speckle tracking echocardiography at rest was significantly lower in patients with significant stenosis and might be useful for identifying patients with a significant stenosis with good degree of sensitivity and specificity.

Deliverability of the Resolute Integrity stent and a post hoc comparison of radial and femoral access: the DELIVER study.

BACKGROUND/PURPOSE: DELIVER (DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER stenting) was a prospective, multicenter, all-comers registry to assess the deliverability of the Resolute Integrity™ zotarolimus-eluting stent (R-ZES). METHODS/MATERIALS: Patients (n=7740 patients, 10449 lesions) undergoing percutaneous coronary intervention and deemed suitable for R-ZES implantation were enrolled and treated according to standard practice of the participating centers in 30 countries. Outcomes included delivery success and in-hospital target lesion failure (TLF), major adverse cardiac event (MACE), and Academic Research Consortium definite/probable stent thrombosis. We performed a post hoc analysis comparing deliverability, in-hospital clinical outcomes and resource utilization with radial vs. femoral access. RESULTS: A high proportion of the population had complex disease (71%): mean lesion length was 26.7±17.5 mm, 35% of lesions were moderately/severely calcified and 17% were bifurcated. Femoral and radial accesses were used in 53% and 46% of patients, respectively. Patients treated using femoral access had more complex coronary artery disease. Primary delivery success was 98.9% and did not differ by approach. Radial access was associated with lower stent and balloon utilization, but higher guide catheter utilization, lower procedure duration, and contrast administered compared with femoral access. In-hospital TLF and MACE occurred in 1.6% of patients; definite or probable stent thrombosis occurred in 0.2%. Clinical outcomes did not differ by vascular access. CONCLUSIONS: R-ZES was found to be highly deliverable in a complex, all-comers, international population, regardless of whether radial or femoral access was used. In-hospital outcomes were excellent with very low risk of complications.

Drug-coated balloons for de novo coronary lesions: results from the Valentines II trial.

AIMS: This study aimed to evaluate the safety and efficacy of using the second-generation DIOR drug-coated balloons (DCB) as an adjunct to plain old balloon angioplasty (POBA) for the treatment of de novo coronary lesions. METHODS AND RESULTS: Valentines II was designed as a prospective, multicentre, multinational, web-based registry. Eligible patients with stable or unstable angina, and/or documented ischaemia on stress testing with de novo lesions of >50% stenosis were prospectively enrolled. Patients underwent POBA followed by DCB treatment. In cases of suboptimal angiographic success (Thrombolysis In Myocardial Infarction [TIMI] flow <3 and/or residual stenosis of >30%), additional bail-out bare metal stenting (BMS) was left at the operator's discretion. The primary endpoint was major adverse cardiac events (MACE; all-cause death, myocardial infarction [MI], target vessel revascularisation [TVR] and vessel thrombosis) at six to nine months. A subset of patients underwent angiographic follow-up. One hundred and nine lesions in 103 patients were treated. Mean age was 62.6±10.2 years; 79.6% were men. Lesion stenosis at baseline and post treatment was 83.3±9.5% and 10.4±10.6%, respectively. Procedural success was 99%. Coronary dissections occurred in 14.7%, and bail-out BMS implantation was required in 13 patients (11.9%). Mean follow-up was 7.5 months; follow-up rate was 99%. Cumulative MACE at follow-up was 8.7%, with 1% all-cause death, 1% MI, 6.9% overall TVR, of which 2.9% were target lesion revascularisations, and no vessel thrombosis. Angiographic follow-up on a subset of patients (n=35) demonstrated late luminal loss of 0.38±0.39 mm for both the in-balloon and in-segment analyses. CONCLUSIONS: The Valentines II trial demonstrates the feasibility of using a second-generation DIOR DCB as adjunct to POBA in de novo coronary lesions. This approach achieved high procedural success with acceptable rates of bail-out stenting and low MACE rates at mid-term follow-up, and offers an attractive alternative for revascularisation of patients who are unsuitable candidates for drug-eluting stents.